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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
data is from secondary source

Data source

Reference
Reference Type:
secondary source
Title:
Robust Summary & Test Plans: Color Former Category: Robust Summary
Author:
U.S. Environmental Protection Agency
Year:
2003
Bibliographic source:
Robust Summary & Test Plans: Color Former Category: Robust Summary, EPA HPV Challenge Color Former Category,2 May 2003

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
Acute dermal toxicity study of 6-Dibutylamino-2-(2'-4'-Dimethylanilino)-3-Methylfluoran (36431-22-8) was performed in rats.
GLP compliance:
not specified
Test type:
other: no data available
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
6-Dibutylamino-2-(2'-4'-Dimethylanilino)-3-Methylfluoran
Cas Number:
36431-22-8
Molecular formula:
C33H32N2O3
IUPAC Name:
6-Dibutylamino-2-(2'-4'-Dimethylanilino)-3-Methylfluoran
Details on test material:
- Name of test material (IUPAC name): 6-Dibutylamino-2-(2'-4'-Dimethylanilino)-3-Methylfluoran
- Common name: Black XV
- Molecular formula: C33H32N2O3
- Molecular weight: 504.627 g/mol
- Smiles notation: O=C1O[C@@]2(c3c(Oc4c2ccc(N(CC)CC)c4)cc(C)c(Nc2c(C)cc(C)cc2)c3)c2c1cccc2
-InChl:1S/C33H32N2O3/c1-6-35(7-2)23-13-14-26-31(18-23)37-30-17-22(5)29(34-28-15-12-20(3)16-21(28)4)19-27(30)33(26)25-11-9-8-10-24(25)32(36)38-33/h8-19,34H,6-7H2,1-5H3
- Substance type: Organic
Specific details on test material used for the study:
- Name of test material (as cited in study report):Black XV
- Molecular formula :C33H32N2O3
- Molecular weight :504.627 g/mol
- Substance type:organic

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS:
- Age at study initiation: Ten to fourteen weeks old
- Weight at study initiation:
male :210 - 227 grams,
female :200 - 207 grams

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
not specified
Details on dermal exposure:
TEST SITE
- Area of exposure: test material was applied uniformly to an area of shorn skin
- % coverage: approximating to 10% of the total body surface area
- Type of wrap if used: selfadhesive bandage (Hypertie).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the area wiped with cotton wool moistened with arachis oil B.P. to remove any residual test material.
- Time after start of exposure: 24 hours
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Total:10 animals
2000 mg/kg bw:5 male and 5 female
Control animals:
not specified
Details on study design:
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of weighing: Individual body weights were recorded on the day of treatment and on days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs: Observed over 14 days with deaths and overt signs of toxicity recorded at 1/2, 1,2 and 4 hours after dosing and subsequently once daily for 14 days
Statistics:
No data available

Results and discussion

Preliminary study:
No data available
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality was observed at dose 2000 mg/kg bw
Mortality:
no mortality was observed at dose 2000 mg/kg bw
Clinical signs:
other: No signs of systemic toxicity or skin irritation were noted during the study.
Gross pathology:
No abnormalities were noted at necropsy of animals killed at the end of the study.
Other findings:
No data available

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The acute dermal median lethal dose (LD50) of the 6-Dibutylamino-2-(2'-4'-Dimethylanilino)-3-Methylfluoran (36431-22-8) in the Sprague-Dawley rat was considered to be >2000 mg/kg bodyweight according to OECD Guideline 402 (Acute Dermal Toxicity).
Executive summary:

In acute dermal toxicity study, 10 male and female Sprague-Dawley rat were treated with 6-Dibutylamino-2-(2'-4'-Dimethylanilino)-3-Methylfluoran (36431-22-8) in the concentration of 2000 mg/kg bw by dermal applicationaccording to OECD Guideline 402 (Acute Dermal Toxicity).Undiluted test material was used. Skin of animals were moistened with arachis oil B.P. The appropriate amount of test material, as received,was pre-weighed into a glass vial, and applied uniformly to an area of shorn skin approximating to 10% of the total body surface area which had been previously moistened with arachis oil B.P. A piece of surgical gauze measuring 7 cm x 4 cm was placed over the treatment area and semi-occluded with a piece of selfadhesive bandage (Hypertie) for 24 hours. After the 24 contact period the bandage was removed and the area wiped with cotton wool moistened with arachis oil B.P. to remove any residual test material. signs of toxicity recorded at 1/2, 1,2 and 4 hours after dosing and subsequently once daily for 14 days. Individual body weights were recorded on the day of treatment and on days 7 and 14.No mortality was observed in treated rats at dose 2000 mg/kg bw.No signs of systemic toxicity or skin irritation were noted during the study. No toxicologically significant effects on bodyweight were noted in the males during the study. One female showed bodyweight loss during the study. No abnormalities were noted at necropsy of animals killed at the end of the study.Therefore, LD50 value was considered to be >2000 mg/kg bw,when rats were treated with 6-Dibutylamino-2-(2'-4'-Dimethylanilino)-3-Methylfluoran (36431-22-8)by dermal application.